What are the benefits and risks of taking part in this study?
Benefits of taking part
Participants will be helping doctors and scientists improve treatment for people who have had heart attacks or strokes, or who may be at risk of having one. If successful, results from this study might help to prevent many thousands of heart attacks, strokes and bypass procedures around the world.
Risks of taking part
Most treatments have side effects, which some people may experience and others may not. If participants do experience any side effects during the study, they will be recorded, so that scientists can learn from these. Participants can stop receiving the study injections any time if they want.
ORION-4 is testing inclisiran, an unlicensed drug. In a previous study including about 350 people treated with inclisiran for 6 months, about 1 in 20 people noticed some redness or soreness where the injection was given, but no other side effects were found. Inclisiran has also been given to over 1500 people in other ongoing studies, however, at this stage, scientists cannot rule out the possibility of there being side effects. All drugs have a potential risk of an allergic reaction, which if not treated promptly, could become life-threatening.
Throughout the study, the research team will carefully monitor participants for possible side effects. At every visit, the study nurse will discuss any new information about the drug.
If anyone does experience unexpected symptoms after joining the study they can contact their ORION-4 nurse, or a study doctor on Freephone 0800 585323.
If participants have private medical insurance or require travel insurance, their policy may be affected. They should check this with their insurance provider.